A framework to assess the maturity of health data registries and CRNs

What is it about?

This article is about developing a structured framework to evaluate how mature and effective health data registries and coordinated registry networks (CRNs) are at generating real-world evidence (RWE) for medical devices. RWE refers to health information collected outside of traditional clinical trials—such as data from electronic health records, patient-reported outcomes, or registries. These sources are becoming essential in assessing the safety and performance of medical technologies over time. The authors worked with 42 experts from healthcare, industry, regulatory agencies, and patient groups to define what makes a registry or CRN “mature.” They used a Delphi process—a structured survey method—to gather feedback and reach agreement on the key features a high-functioning system should have. The final framework includes seven domains, such as data quality, device identification, governance, and patient outcomes. Each domain has five levels of maturity, from basic to advanced. The goal of this framework is to help developers, funders, and regulators assess and improve these systems so they can produce high-quality evidence. The framework is also flexible—it’s meant to evolve as technology and healthcare systems change.

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Photo by Jair Lázaro on Unsplash

Photo by Jair Lázaro on Unsplash

Why is it important?

Real-world evidence (RWE) is increasingly used to support healthcare decisions, especially for medical devices. However, not all registries or data systems are equally capable of collecting reliable, high-quality information. Without strong evidence systems, it becomes harder for regulators, clinicians, and patients to assess the safety and effectiveness of new devices—particularly once they are in widespread use. This can delay important decisions, increase costs, or even lead to patient harm, as seen with some past device failures (e.g., hip implants or surgical mesh). This new maturity framework provides a standardized way to evaluate and improve the systems that collect RWE. By breaking down the components of an effective registry or CRN into seven clear domains with defined stages of progress, the framework helps identify where a system is strong and where it needs investment. For example, it can guide improvements in how devices are tracked, how patient feedback is collected, or how data is shared. Importantly, the framework supports international consistency, making it easier for different health systems and countries to collaborate. In a global healthcare environment, shared standards and reliable data are critical for timely, informed decision-making about medical technologies. --------------------------- Some of the content on this page has been created using generative AI.